Polymorphic Generation through Solvent Selection:  Ranitidine Hydrochloride

The fundamental processes of crystal nucleation and growth are strongly dependent on the solvents used in the crystallization process. Consequently, the product quality is also affected by the choice of solvent used in the process. In this study, several solvents were used, and their impact on the polymorphic generation of ranitidine hydrochloride (RAN-HCl) was studied using two different recrystallization modes. The solid-state FTIR and UV spectrophotometer were used for characterization and quantification of two polymorphic forms of RAN-HCl. It was found that methanol concentration greater than 10 wt % at nucleation onset favored formation of Form 2. The best results with respect to the solid bulk density were achieved with acetonitrile as an antisolvent.